510(k) Report

FDA applicant

Omni Therm, Inc.

St. Louis, MO5 decisions1987–19966 recalls

FDA records 5 decisions for Omni Therm, Inc. (St. Louis, MO) from 1987 to 1996: 5 510(k) clearances. Most are in product codes IMD (Pack, Hot Or Cold, Disposable) and KPD (Strip, Temperature, Forehead, Liquid Crystal). 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Omni Therm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omni Therm, Inc. since 2007.

Recalls per year

4in 2021

2015: 12016: 12021: 4
2007high 4 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Omni Therm, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IMDPack, Hot Or Cold, Disposable4decisions
  • KPDStrip, Temperature, Forehead, Liquid Crystal1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K936084Omni Warm Gel PacksOmni Therm, Inc. · 19942cite it

What has FDA decided for it lately?

  • K961176Omni Cold Gel PacksOmni Therm, Inc. · 1996
  • K955788Imni Hot PacksOmni Therm, Inc. · 1996
  • K954877Omni Cold Gel PacksOmni Therm, Inc. · 1996
  • K936084Omni Warm Gel PacksOmni Therm, Inc. · 19946 recalls
  • K864853Omni Therm Temperature MonitorOmni Therm, Inc. · 1987

All 5 as Omni Therm, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K936084Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010TNov 29, 2021Class II
  • K936084Infant Heel Warmers w/strap, Reference # 989805603201 1223Nov 29, 2021Class II
  • K936084Medichoice Infant Heel Warmer, Reference # 989805643721 1079906Nov 29, 2021Class II
  • K936084Infa-Therm Transport Mattress, Reference Number 989805616831 1015Nov 26, 2021Class II
  • K936084evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer…Feb 10, 2016Class II
  • K936084Cardinal Health Tiny Toes; 11470-010T Infant heel warmerNov 20, 2015Class II

Other applicant names beginning “Omni”

FDA records each applicant name separately; these may or may not be the same firm.

Omni Life Science, Inc. 21Omni Intl., Inc. 12Omni Hearing Systems 7Omni-Tract Surgical, Div. Minn. Scientific, Inc. 4Omni Surgical, L.P. 2Omni-Guide Holdings, Inc. 2Omni Sales Corp. 2Omni Mfg., Inc. 1Omni Medical Designs 1Omni-Flow, Inc. 1Omni Surgical, LLC Dba Spine360 1Omni Surgical, LP Dba Spine360 1